Health TrialsbyHealthPanel

Statins to Prevent Cancer Associated Blood Clots

ConditionsVenous ThromboembolismCancerCardiovascular Events
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

Patients with cancer are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage.

The primary aim of the Statin Therapy to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who do not otherwise take statin therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18 years with no contraindication to statin therapy and able to provide informed consent

newly diagnosed, newly recurrent or newly progressive malignancy with locally advanced/metastatic disease initiating new systemic cancer therapy with no plan for prophylactic anticoagulation.

intermediate or high risk for cancer associated VTE based on the Khorana Score (KS) and modified Khorana Score (mKS) risk assessment tools (KS 2-4 or mKS 2-5).

ECOG performance status 0-2

Disqualifiers

current use of statin therapy or known statin intolerance.

current use of systemic anticoagulation.

very low VTE risk defined by a Khorana Score (KS) of 0-1 and a modified Khorana Score (mKS) of 0-1.

extremely high VTE risk defined by a Khorana Score (KS) > 5 or modified Khorana Score (mKS) > 6 where guideline recommendations for systemic anticoagulation should be considered.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rosuvastatin

    Drug

    Rosuvastatin is a statin drug that helps reduce cholesterol and can help reduce risks of blood clots. In this study, patients will take 20mg of Rosuvastatin (or placebo) for to 12 months.

  • Placebo Drug

    Drug

    The placebo pills are pills with no medicine in them.

Treatment groups

4,000 Participants
are divided into 2 treatment groups
Group A: Active Rosuvastatin ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer

The primary endpoint of the trial is the time from taking the first dose of study medication after randomization (modified intention to treat, mITT) to the first confirmed occurrence of the primary VTE endpoint. The primary analysis will use a likelihood ratio test based on a proportional hazards model stratified by eligibility criteria (eligible due to KS criteria alone or eligible due to mKS criteria), and enrollng center to test the null hypothesis of no association between assignment to active statin treatment and the rate of the primary endpoint. All analyses will classify patients according to their randomized treatment assignment, i.e. according to the intention to treat principle, and will base evaluation of statistical significance on a two-sided test with level 0.05. The estimated relative hazard in the statin compared to the placebo group with accompanying 95% confidence interval will quantify the treatment effect45. If this relative hazard is less than 1, then 100\*(1-esti

Time frame
12 months

Secondary outcomes

1

Assess whether Rosuvastatin versus placebo over a period of one year reduces the cumulative incidence of a composite of venous and arterial thrombosis events among patients with cancer

Time frame
12 months

Other outcomes

1

Safety Endpoint: Identify transaminitis > 5 x ULN on two consecutive tests at least one week apart

Time frame
12 months
2

Safety Endpoint: Identify CK > 5 x ULN on two consecutive tests at least one week apart

Time frame
12 months
3

Safety Endpoint: Identify clinical myositis, rhabdomyolysis, major bleeding and clinically relevant non-major bleeding

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Dana-Farber/Brigham and Women's Cancer Center

Collaborator

Source ClinicalTrials.gov
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